Regulatory Affairs Manager

Description

• Assist in aligning local regulatory requirements with Amgen’s corporate standards.
• Provide national/regional (as applicable) input to and execute regulatory strategies.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
• Act as the point of contact with regulatory agencies.
• Develop, communicate and coordinate the regulatory strategy for pipeline
• Plan and manage clinical trial applications through CRO and liaise/coordinate CTA response to queries between CRO and Amgen.
• Manage CRO work invoice and participate in global network.
• Work as a primary point of contact and oversight for Global Regulatory Affairs & Safety (GRAAS) between the in-country Functional Service Provider (FSP) and Amgen, ensuring that the FSP delivers per contract as well as the timelines and quality of all regulatory and safety filings.
• • Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
  • With general supervision, executes the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable.
  • Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
  • Creates, reviews and approves source text for country labeling, and owns the country artwork based on source text.
  • Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).
  • Reviews and approves the promotional and non-promotional materials.
  • Monitors changes in the local Trade Associations/national legislation and forwards information to local/regional groups communicating the impact to Amgen.
  • Monitors the external regulatory environment to help inform/advise in the regulatory decision making.
  • Ensures/supports regulatory product compliance (e.g. RIM, PMCs, pediatric and other agency commitments, Renewal).
    
    
  HEALTH AUTHORITY INTERACTIONS
  
  
  • Acts as the point of contact with regulatory agencies in fulfilling local obligations.
  • Participates/contributes to local agency interactions and their preparation.
    
    
  COMMUNICATION AND COLLABORATION
  
  
  • Works closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver Affiliate/Hub goals.
  • Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.
  • Partners with International Regulatory Leads (IRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.
  • Partners with peers to ensure consistency on procedures.
  • Acts as contact and create relationships with Agency staff on specific product assignment (if applicable).
  • Establishes regular contacts and interactions with Distributors (if applicable).
    
    
  COUNTRY SPECIFIC ACTIVITIES
  
  
  • Assists locally in Healthcare Compliance activities where applicable.
  • Participates in local regulatory process improvements, initiatives and training.
  • Oversees external vendor/contractor relationships where applicable.

Qualifications

Scientific and Technical

• Knowledge of Regulatory principles.
• Working with policies, procedures and SOP’s.
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• General knowledge of national legislation and regulations relating to medicinal products.
• General awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
• Knowledge and experience in the country(ies) regulatory environment relevant for product area and development stage.
• Understanding of drug development.

Others

• Demonstrate strong team work ability.
• Good communication skills - both oral and written.
• Good negotiation and Influencing skills.
• Ability to understand and communicate scientific/clinical information.
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
• Cultural awareness and sensitivity to achieve results across both regional, country and International borders.
  
  

Education & Experience
Basic

• Doctorate or Master’s degree (scientific area) and 3 years of directly related experience OR Bachelor’s degree (scientific area) and 5 years of directly related experience